Identity
- Trade Name
- Dowell Dental Products, Inc FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI
- Device Name
- 5 PCS CASSETTE FDA UDI
- Model / Reference
- MS1259 FDA UDI
- Description
- 5 PCS CASSETTE FDA UDI
Identifiers
- Primary DI / UDI-DI
- D961MS12590 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental/maxillofacial surgical procedure kit, medicated, reusable
Dowell Dental Products, Inc by Dowell Dental Products, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, medicated, reusable.
- TRU®/PUR® Surgical Kit - No Tools — Sterngold Dental LLC · Class I
- TRU®/PUR® Surgical Kit — Sterngold Dental LLC · Class I
- MOR® Surgical Kit — Sterngold Dental LLC · Class I
- Sterngold Implant System Guided Surgery Kit — Sterngold Dental LLC · Class I
- Sterngold Implant System Guided Surgery Kit (no tools) — Sterngold Dental LLC · Class I
- Stern Snap Dentist Tool Kit — Sterngold Dental LLC · Class I
- MOR® Surgical Kit - No Tools — Sterngold Dental LLC · Class I
- Dowell Dental Products, Inc — Dowell Dental Products, Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dowell Dental Products, Inc
Sources (1)
- FDA UDI 75665858-18f7-474e-8a03-250f911d0f92 33 fields · synced May 30, 2026